Health Canada grants priority review to Filsuvez for EB wound care
Decision based on EASE trial data showing faster wound closure with Filsuvez
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Health Canada has granted priority review to Chiesi Global Rare Diseases’ application seeking approval of Filsuvez (birch triterpenes), a topical gel to treat skin wounds in people with dystrophic epidermolysis bullosa (DEB) or junctional epidermolysis bullosa (JEB), ages 6 months or older.
Priority review is granted to therapies for serious or life-threatening conditions when there are limited or no comparable treatment options, or when the therapy may offer a meaningful improvement over existing care. It shortens the regulatory review period to about six months from the standard 10 months.
Priority review could shorten Canada decision timeline
“Priority Review acceptance by Health Canada marks an important regulatory milestone in the review for FILSUVEZ in Canada for people living with this rare, genetic, and often debilitating condition,” Mitch Goldman, MD, PhD, senior vice president of R&D at Chiesi Global Rare Diseases, said in a company press release. Goldman added: “We are hopeful that this milestone brings us closer to our goal of advancing rare disease care in Canada and supporting those living with EB.”
Erin Hoyos, executive director of DEBRA Canada, added that “Health Canada’s Priority Review of FILSUVEZ is an important milestone for the EB community and reflects continued progress in the evaluation of potential treatment options for people living with this condition in Canada.”
Epidermolysis bullosa is a group of diseases marked by extremely fragile skin that tears and blisters easily. DEB and JEB are among the most severe types of EB, caused by gene mutations that disrupt the production of proteins that hold skin layers together.
Irene Lara-Corrales, MD, pediatric dermatologist at The Hospital for Sick Children in Toronto, said that EB “remains highly challenging to manage, with patients often experiencing recurrent wounds, pain, infections, and other serious complications throughout their lives. The disease can also place a substantial physical, emotional, and caregiving burden on patients and families, often requiring ongoing multidisciplinary care and support.”
Filsuvez’s active ingredient is a birch tree bark extract containing triterpenes, molecules believed to accelerate wound repair by easing inflammation and promoting skin cell growth to restore the skin barrier.
EASE trial data support priority review decision
In the EASE study, more than 200 patients, ranging from infancy to adulthood, with JEB or DEB were randomly assigned to receive Filsuvez or a control gel for approximately 90 days. Researchers selected one target wound to measure wound closure, while the gel was applied directly to wounds or to wound dressings at least every four days.
Filsuvez was associated with significantly higher rates of target wound closure than the control gel in the first 45 days (41.3% vs. 28.9%), reflecting a 44% increase in the probability of wound closure with Filsuvez. Target wound size also decreased over the 90-day study period.
After completing the main trial, patients could enroll in a two-year open-label extension phase, where all received the treatment. Long-term findings showed Filsuvez was associated with reductions in skin disease burden and the percentage of body surface area covered in wounds, along with maintained improvements in pain and itching.
The most common side effects of Filsuvez reported in clinical trials have been reactions at the application site, such as itching or pain. Long-term data showed that the therapy was generally well tolerated.
Results from EASE also supported Filsuvez’s approval in the U.S. and the European Union.
“An approved therapy in Canada for individuals living with EB would represent an important potential advancement for the community,” Lara-Corrales added.
